Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000132
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Early Manifest Glaucoma Trial EMGT
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose is to compare the effect of immediate therapy to lower the intraocular pressure IOP versus late or no treatment on the progression of newly detected open-angle glaucoma as measured by increasing visual field loss andor optic disc changes
The secondary purposes are to determine the extent of IOP reduction attained by treatment to explore factors that may influence glaucoma progression and to describe the natural history of newly detected glaucoma
The secondary purposes are to determine the extent of IOP reduction attained by treatment to explore factors that may influence glaucoma progression and to describe the natural history of newly detected glaucoma
Detailed Description:
Glaucoma is a common disease in older adults All present treatment aims at reduction of the intraocular pressure but indications for therapy are not well defined Furthermore it is unclear whether intraocular pressure influences the natural history of glaucoma Against this background the primary aim of the study is of central importance to patients with manifest and suspect glaucoma
Glaucoma has few subjective symptoms during a long period early in the disease but damage is irreversible once it occurs Early diagnosis and rapid detection of progression are of paramount importance in limiting this damage whether through pressure reduction or in some other way The effectiveness if any of lowering the intraocular pressure in glaucoma requires evaluation by controlled treatment trials
The Early Manifest Glaucoma Trial EMGT is the first large controlled randomized clinical trial to evaluate the effect of lowering the intraocular pressure on the progression of newly detected open-angle glaucoma This study will compare glaucoma progression in initially treated versus untreated patients with newly detected open-angle glaucoma and will allow quantification of the effect of immediate IOP-lowering treatment on progression during the followup period
The EMGT is a collaborative effort that involves a Clinical Center at the Department of Ophthalmology of Malmo University Hospital at the University of Lund Sweden and its Satellite Center in Helsingborg Sweden an independent Data Center at the Department of Preventive Medicine University Medical Center at Stony Brook New York and a Disc Photography Reading Center at the Department of Ophthalmology in Lund at the University of Lund The study was initiated with support from the Swedish Medical Research Council
Recruitment for the study has been completed The 255 patients were identified by an extensive population-based screening of successive age cohorts as well as by clinical referral The diagnosis was confirmed through Humphrey perimetry at two postscreening visits to the Clinical Center or Satellite Center Eligible patients who agreed to participate had two additional visits for collection of baseline data They were randomized to treatment with the beta blocker Betaxolol and argon laser trabeculoplasty treated group or to no initial treatment control group with close followup of both groups
Patients are followed for a minimum of 4 years to assess the development of glaucoma progression They are seen every 3 months to collect visual field IOP and other data Disc photographs are taken every 6 months Technicians and disc photograph graders are masked regarding treatment assignment Additional followup visits are held to confirm visual field progression and IOP elevation 25 mm Hg in treated group 35 mm Hg in control group Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at more than one visit patients in the control group will receive Xalantan whenever IOP reaches 35 mm Hg or higher during the trial If IOP remains high individualized treatment is given All patients continue to be followed to monitor the development of end points and will be analyzed in their originally assigned groups
The study outcome is glaucoma progression which is based on specific criteria derived from analyses of Humphrey visual fields and masked evaluations of disc photographs The perimetric outcome is defined as statistically significant deterioration p 005 of the same three or more test points in Pattern Deviation Change Probability Maps in three consecutive C30-2 Humphrey fields Optic disc progression is determined by the following
The presence of definite change detected by comparison of followup photographs with baseline by flicker chronoscopy in two followup photographs from the same visit with independent confirmation by side-by-side gradings
Final confirmation of change toward progression by flicker chronoscopy and by side-by-side gradings at a different followup visit
Glaucoma has few subjective symptoms during a long period early in the disease but damage is irreversible once it occurs Early diagnosis and rapid detection of progression are of paramount importance in limiting this damage whether through pressure reduction or in some other way The effectiveness if any of lowering the intraocular pressure in glaucoma requires evaluation by controlled treatment trials
The Early Manifest Glaucoma Trial EMGT is the first large controlled randomized clinical trial to evaluate the effect of lowering the intraocular pressure on the progression of newly detected open-angle glaucoma This study will compare glaucoma progression in initially treated versus untreated patients with newly detected open-angle glaucoma and will allow quantification of the effect of immediate IOP-lowering treatment on progression during the followup period
The EMGT is a collaborative effort that involves a Clinical Center at the Department of Ophthalmology of Malmo University Hospital at the University of Lund Sweden and its Satellite Center in Helsingborg Sweden an independent Data Center at the Department of Preventive Medicine University Medical Center at Stony Brook New York and a Disc Photography Reading Center at the Department of Ophthalmology in Lund at the University of Lund The study was initiated with support from the Swedish Medical Research Council
Recruitment for the study has been completed The 255 patients were identified by an extensive population-based screening of successive age cohorts as well as by clinical referral The diagnosis was confirmed through Humphrey perimetry at two postscreening visits to the Clinical Center or Satellite Center Eligible patients who agreed to participate had two additional visits for collection of baseline data They were randomized to treatment with the beta blocker Betaxolol and argon laser trabeculoplasty treated group or to no initial treatment control group with close followup of both groups
Patients are followed for a minimum of 4 years to assess the development of glaucoma progression They are seen every 3 months to collect visual field IOP and other data Disc photographs are taken every 6 months Technicians and disc photograph graders are masked regarding treatment assignment Additional followup visits are held to confirm visual field progression and IOP elevation 25 mm Hg in treated group 35 mm Hg in control group Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at more than one visit patients in the control group will receive Xalantan whenever IOP reaches 35 mm Hg or higher during the trial If IOP remains high individualized treatment is given All patients continue to be followed to monitor the development of end points and will be analyzed in their originally assigned groups
The study outcome is glaucoma progression which is based on specific criteria derived from analyses of Humphrey visual fields and masked evaluations of disc photographs The perimetric outcome is defined as statistically significant deterioration p 005 of the same three or more test points in Pattern Deviation Change Probability Maps in three consecutive C30-2 Humphrey fields Optic disc progression is determined by the following
The presence of definite change detected by comparison of followup photographs with baseline by flicker chronoscopy in two followup photographs from the same visit with independent confirmation by side-by-side gradings
Final confirmation of change toward progression by flicker chronoscopy and by side-by-side gradings at a different followup visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None